MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-12 for THERMOPHORE 055 manufactured by Battle Creek Equipment.
[182930714]
Customer stated, "there was a spark from the switch. User claimed that they laid on the unit while using. " product was returned. Customer did not claim injury. The investigator observed no evidence of sparking during the investigation. Additionally the investigator observed evidence to corroborate the users claim of misusing the product by laying on the unit. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11085 |
| MDR Report Key | 9702640 |
| Report Source | CONSUMER |
| Date Received | 2020-02-12 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL GREEN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOPHORE |
| Generic Name | THERMOPHORE |
| Product Code | IRT |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-01-30 |
| Model Number | 055 |
| Lot Number | 00055318183 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BATTLE CREEK EQUIPMENT |
| Manufacturer Address | 702 S REED RD FREMONT, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |